BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIM ARM/LAT/F/MULTILOC PROXIMAL HUM NL

    MDR report key: 12847290 · Received November 19, 2021

    Report

    Report Number
    2939274-2021-06763
    Event Type
    Malfunction
    Date Received
    November 19, 2021
    Date of Event
    January 1, 2021
    Report Date
    October 26, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    UDI-DI
    10886982069450
    PMA / PMN Number
    K103002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT OCCURRED ON AN UNKNOWN DATE IN 2021. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT: PART: 03.019.008, LOT: 8241546, MANUFACTURING SITE: (B)(4), SUPPLIER: N/A, RELEASE TO WAREHOUSE DATE: 12 MARCH 2013, EXPIRATION DATE: N/A. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2021 DURING AN UNKNOWN PROCEDURE, ONE (1) AIMING ARM, ONE (1) INSERTION HANDLE, AND ONE (1) UNKNOWN DISTAL SCREW WERE UNABLE TO ASSEMBLE CORRECTLY. THE HANDLE AND AIMING ARM MALFUNCTIONED AND MISSED THE NAIL AND WERE UNABLE TO USE THE DISTAL SCREW. THERE WAS A SURGICAL DELAY OF FIFTEEN (15) MINUTES. THERE WAS NO PATIENT CONSEQUENCE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) AIM ARM/LAT/F/MULTILOC PROXIMAL HUM NL. THIS IS REPORT 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1744504 AIM ARM/LAT/F/MULTILOC PROXIMAL HUM NL ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.019.008 8241546 10886982069450

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown INSRT HNDL FOR MULTILOC HUM NLING SYS| UNK - NAILS| UNK - SCREWS: NAIL LOCKING